Sr. Data Scientist, Assay Development
Core
Design studies and analyze data to evaluate assay performance, inform product decisions, and support regulatory submissions for early cancer detection blood tests.
Role type
Senior Data Scientist (Assay Development & Regulatory Diagnostics)
Builds
Laboratory-developed tests (LDT) and In Vitro Diagnostic (IVD) products for cancer detection
Domain
Diagnostics / Oncology / Genomics
Deliverable
production ML models
Required skills
Statistical foundations (hypothesis testing, equivalence testing, variance components), Regulated diagnostics experience (IVD/LDT), Study design, Python/R, Design of Experiments, Root cause analysis
Preferred skills
Production monitoring, Assay transfer, NGS-based assays, FDA design controls
Technologies
Python, R
Responsibilities
Design studies and analyze data to evaluate assay performance, Develop statistical methods for production monitoring, Assess impact of changes and design bridging studies, Support verification and transfer to production, Support regulatory submissions, Lead data analysis for troubleshooting and investigations
Seniority
Senior, hands-on IC